On December 4, 2019 Karus Therapeutics Ltd (‘Karus’), a clinical-stage biopharmaceutical company developing precision medicines for cancer, reported that new data will be presented from its KA2237 Phase I study at the ASH (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida, 9 December 2019 (Press release, Karus Therapeutics, DEC 4, 2019, View Source [SID1234551928]).

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The Phase I clinical trial, conducted at The University of Texas MD Anderson Cancer Center, has examined the safety, tolerability, pharmacokinetic properties and pharmacodynamic effects of KA2237 in patients with relapsed/refractory B-cell lymphoma.

KA2237 is a potent, orally-active and dual-selective PI3 Kinase (PI3K) p110β/δ inhibitor. The p110δ isoform is an attractive therapeutic target, with several known inhibitors demonstrating efficacy in B-cell lymphomas. Karus aims to overcome mechanisms of tumor escape by simultaneously targeting PI3K p110β.

Tim Edwards, Karus’ Executive Chairman, commented:

"As we continue in our mission to develop transformative precision medicines for cancer, ASH (Free ASH Whitepaper) provides the perfect opportunity to showcase the potential of KA2237 in the treatment of hematological and solid tumors. We are pleased to be presenting our new data and look forward to connecting with more of the hematology community."

Details of the poster presentation are as follows:

Title: 4099. Results of a First in Human, Dose Ascending, Phase I Study Examining the Safety and Tolerability of KA2237, an Oral p110β/δ Inhibitor in Patients with Relapsed/Refractory (R/R) B-Cell Lymphoma
Time and Date: 18:00–20:00, Monday 9 December
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Presenters: Dr Loretta Nastoupil, MD (on behalf of MD Anderson Cancer Center) and Dr Philip Beer, MD, PhD (on behalf of Karus).

On December 4, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Bortezomib for Injection 3.5 mg/vial, approved by the U.S. Food and Drug Administration (USFDA) via a 505(b)(2) new drug application (NDA) pathway for intravenous use only (Press release, Dr Reddy’s, DEC 4, 2019, View Source [SID1234551927]).

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"We’re pleased to bring this product to market for the customers and patients who will benefit from this cost-efficient alternative in the marketplace," explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. "This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio of products in the Hospital segment."

Dr. Reddy’s Bortezomib for Injection 3.5 mg/vial is for intravenous use only and is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Important Safety Information:

What Important Information Should I Know About Bortezomib for Injection, 3.5 mg/Vial?

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy
For intravenous use only. Do not administer Bortezomib for injection by any other route
Bortezomib for injection retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with bortezomib and who have relapsed at least six months after completing prior bortezomib treatment. Treatment may be started at the last tolerated dose
Bortezomib can cause fetal harm when administered to a pregnant woman
Who Should Not Use Bortezomib for Injection, 3.5 mg/Vial?

Patients with hypersensitivity (not including local reactions) to bortezomib or boron. Reactions have included anaphylactic reactions
Bortezomib for injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib products
If you are or plan on being pregnant. Females of reproductive potential should avoid becoming pregnant while being treated with Bortezomib for injection because of potential risk to the fetus and should use effective contraception during treatment with Bortezomib for injection and for seven months following the final dose
Males with female sexual partners of reproductive potential should not father a child and must use effective contraception during treatment with Bortezomib for injection and for four months following treatment
Females should not breastfeed during treatment with Bortezomib for injection and for two months after treatment
What should I tell my healthcare provider before taking Bortezomib for Injection, 3.5 mg/Vial?

Before taking Bortezomib for Injection, tell your doctor if you previously have had or currently do have:

Preexisting symptoms (numbness, pain or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy
History of syncope, receiving medications known to be associated with hypotension, and are dehydrated which may increase risk of hypotension
Are at risk factors for, or have existing heart disease
Have high tumor burden, risk of tumor lysis syndrome
Are pregnant or plan to be pregnant
Are nursing
If you are receiving dialysis
Have moderate or severe hepatic impairment
Are taking medications for diabetes
Are using other prescription and non-prescription medications and/or dietary and herbal supplements
What are possible side effects of Bortezomib for Injection, 3.5 mg/Vial?

Call your doctor or get emergency help right away if you develop:

Peripheral Neuropathy
Hypotension
Cardiac Toxicity
Pulmonary Toxicity
Posterior Reversible Encephalopathy Syndrome (PRES)
Gastrointestinal Toxicity
Thrombocytopenia
Neutropenia
Tumor Lysis Syndrome
Hepatic Toxicity
Thrombotic Microangiopathy
Please refer to the Package Insert for a complete list of possible side effects associated with Bortezomib for Injection

What are the most common side effects of Bortezomib for Injection, 3.5 mg/Vial?

Nausea
Diarrhea
Thrombocytopenia
Neutropenia
Peripheral neuropathy
Fatigue
Neuralgia
Anemia
Leukopenia
Constipation
Vomiting
Lymphopenia
Rash
Pyrexia
Anorexia
Dizziness
Syncope
What should I avoid while taking Bortezomib for Injection, 3.5 mg/Vial?

Females of reproductive potential should avoid becoming pregnant while being treated with Bortezomib for injection. Females of reproductive potential must use contraception during treatment with Bortezomib for injection and for seven months following treatment
Avoid breastfeeding while receiving Bortezomib for injection and for two months after last dose
Avoid coadministration with medications that are strong CYP3A4 inducers
Avoid dehydration due to risk of hypotension, gastrointestinal toxicity, tumor lysis syndrome – Patients should drink adequate fluids
Bortezomib may cause fatigue, dizziness, syncope, orthostatic/postural hypotension, therefore Patients should not drive or operate machinery if they experience any of these symptoms
For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy’s Laboratories Medical Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to [email protected] or contact the USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at View Source

On December 4, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported the pricing of an underwritten public offering of 4,000,000 shares of its common stock, offered at a price of $58.00 per share, before underwriting discounts (Press release, Arrowhead Pharmaceuticals, DEC 4, 2019, View Source [SID1234551925]). The offering is expected to close on or about December 6, 2019, subject to customary closing conditions. In addition, Arrowhead has granted the underwriters of the offering a 30-day option to purchase up to an additional 600,000 shares of common stock at the public offering price, less the underwriting discount. Gross offering proceeds will be approximately $232 million, before deducting underwriting discounts and commissions and offering expenses.

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Goldman Sachs & Co. LLC, Jefferies LLC and Piper Jaffray & Co. are acting as bookrunning managers for the offering, Cantor Fitzgerald & Co. is acting as passive joint bookrunner for the offering and Robert W. Baird & Co. Incorporated and B. Riley FBR, Inc. are acting as co-managers for the offering. Arrowhead intends to use the net proceeds from this offering for general corporate purposes, including working capital, capital expenditures, research and development expenditures and clinical trial expenditures. A portion of the net proceeds may also be used for the acquisition of complementary businesses, products and technologies, or for other strategic purposes.

A shelf registration statement on Form S-3 (File No. 333-235324) relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became automatically effective upon filing on December 2, 2019. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On December 4, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis), for the treatment of various cancers including leukemia, prostate and colorectal, reported new in-vitro and in-vivo data suggesting that onvansertib may provide a new therapeutic option for patients who develop resistance to frontline treatment with venetoclax (Press release, Trovagene, DEC 4, 2019, View Source [SID1234551924]).

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The data show that onvansertib, as a single agent, inhibits tumor growth in venetoclax (Venclexta – Abbvie) resistant in-vitro and in-vivo models. Additionally, the data also demonstrate synergy with the combination of onvansertib and venetoclax, providing further support for the ability of onvansertib to rescue patients once they show signs of resistance to venetoclax. Currently, there are no viable treatment options for patients once they develop resistance to venetoclax; the median overall survival is only 1.7 to 2.3 months and prognosis is poor. Onvansertib represents a new therapeutic option to treat venetoclax-resistant AML and potentially increase progression-free and overall survival for these patients.

"We are very encouraged by the data suggesting that onvansertib will be able to rescue AML patients once they develop resistance to frontline treatment with venetoclax," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. "In our current Phase 2 AML trial, we are targeting venetoclax-resistant patients and treating them with the combination of onvansertib plus hypomethylating agent decitabine. We are also considering plans to conduct a future clinical trial of onvansertib in combination with venetoclax in patients showing initial signs of resistance to venetoclax to provide a new therapeutic option in an indication with significant clinical need."

AML is the most common acute leukemia in adults and is most frequently diagnosed in those 65 to 74 years of age. Prognosis is generally poor and worsens with advanced age. Current first-line treatment options for AML include induction chemotherapy; however, many older patients are not candidates for this treatment option. With the introduction of venetoclax, the treatment landscape has evolved and elderly patients who are not eligible for intensive chemotherapy are receiving venetoclax in combination with a hypomethylating agent frontline. Resistance tends to develop within approximately 11 months following initiation of treatment with venetoclax and today there are no viable therapies for these patients and their prognosis is poor. Thus, there is a significant medical need for new therapeutic options to treat patients once they develop resistance to venetoclax.
About the Ongoing Phase 2 Clinical Trial of Onvansertib in AML

Trovagene Inc. | 11055 Flintkote Avenue | San Diego | CA 92121 | Tel.: USA [+1] 888-391-7992

The ongoing multi-center open label Phase 2 AML trial (NCT03303339) of onvansertib in combination with decitabine will enroll a total of 32 patients. Eligible patients are either treatment naïve and not candidates for induction therapy or have relapsed/refractory disease following treatment with one prior regimen, including patients treated with venetoclax in combination with a hypomethylating agent. Patients will receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine. The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.

About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML (NCT03303339). Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.

Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On December 4, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported the successful completion of a constructive Type B pre-BLA meeting with the FDA regarding the final Chemistry, Manufacturing and Controls (CMC) content of the Company’s Biologics License Application (BLA) for Vicinium (Press release, Sesen Bio, DEC 4, 2019, View Source [SID1234551923]). As previously announced, the Company expects to initiate the submission of the BLA for Vicinium in December 2019.

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"After four highly collaborative and productive meetings with the FDA in 2019, we feel increasingly confident in the regulatory path forward for Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio.

Sesen Bio reached agreement with the FDA on the final content of the BLA and no further meetings were requested by the FDA at this time. The Company also gained a clear understanding of the FDA’s requirements for the process performance qualification (PPQ) campaign for bulk drug substance and drug product manufacturing. In addition, the Company continues to work in partnership with the FDA to accelerate the timing of the Pre-License Inspection (PLI) of the drug substance manufacturer, which is anticipated to expedite review of the BLA.

Additional details on regulatory progress in support of the potential approval of Vicinium are expected to be announced this December.

Key December 2019 Events

Anticipated initiation of BLA submission under a Rolling Review
Sesen Bio Regulatory Update
About Vicinium
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicinium promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.